Plaque PsoriasisRESTORENCT00402818
RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization
An observational study of Plaque Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.
Trial summary
RESTORE is an observational, open-label, multi-center, prospective, study enrolling Raptiva® (efalizumab) treated patients with moderate to severe chronic plaque psoriasis. The overall duration of the study is approximately 4 years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis
- How many people
- 294 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consenting Raptiva® (efalizumab) treated patients with moderate to severe chronic plaque psoriasis and meeting the inclusion/exclusion criteria specified will be eligible for participation in this study. Subjects will be enrolled from the Raptiva®-treated clinical patient pool at the participating Canadian investigator site.
Who may be able to join
- Male or female ≥ 18 years old.
- Have a clinical diagnosis of moderate to severe chronic plaque psoriasis and be a candidate for treatment with Raptiva®.
- Are being treated or are initiating treatment with Raptiva® at time of study enrolment in accordance with the Canadian Product Monograph indication and recommendations.
- Be able to provide written informed consent.
- Agreement to participate in the study, and to disclose any medical events to the Investigator.
- The subject must be willing and able to comply with the protocol requirements for the duration of the study.
Who cannot join
- Any contra-indication to Raptiva® according to the Canadian Product Monograph.
- Any simultaneous participation in another clinical evaluation trial for psoriasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RESTORE (Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization Registry) Observational, Open-label, Multi-centre, Phase IV Study of Subcutaneously Administered Raptiva® (Efalizumab) in the Treatment of Adult Patients With Moderate to Severe Chronic Plaque Psoriasis Who Are Candidates for Treatment With Raptiva®
RESTORE is an observational, open-label, multi-center, prospective, study enrolling Raptiva® (efalizumab) treated patients with moderate to severe chronic plaque psoriasis. The overall duration of the study is approximately 4 years. Patients will be followed from the time of study enrolment to study/treatment termination; thus active follow-up period will vary across subjects. Raptiva® (efalizumab)treated patients with moderate to severe chronic plaque psoriasis and meeting the inclusion/exclusion criteria specified will be eligible for participation in this study.
Objectives:
- To document and quantify the incidences of adverse events in this patient population
- To explore the association of psoriasis treatments with changes in patient outcomes, quality of life, and treatment compliance.
- Conditions
- Plaque Psoriasis
- Keywords
- Moderate to severe plaque psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
All serious and unexpected AEs
Measured: During the course of the study
Secondary outcomes (1)
Investigator assessed: static Physician's Global Assessment (sPGA). Patient assessed: Dermatology Life Quality Index (DLQI)
Measured: During the course of the study, there are no pre-defined scheduled visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: The study was terminated after the EMEA recommended to suspend the marketing authorisation of Raptiva in the EU
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Horia Ijacu, MD, Study director, EMD Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402818
- Sponsor's protocol ID
- 26768
- Acronym
- RESTORE
- Status last verified
- Aug 2014
- First submitted
- 20 Nov 2006
- Last updated
- 29 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE (Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization Registry) Observational, Open-label, Multi-centre, Phase IV Study of Subcutaneously Administered Raptiva® (Efalizumab) in the Treatment of Adult Patients With Moderate to Severe Chronic Plaque Psoriasis Who Are Candidates for Treatment With Raptiva®
- ClinicalTrials.gov ID
- NCT00402818
- Acronym / sponsor ID
- RESTORE / 26768
- Conditions
- Plaque Psoriasis
- Keywords
- Moderate to severe plaque psoriasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated after the EMEA recommended to suspend the marketing authorisation of Raptiva in the EU
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RESTORE is an observational, open-label, multi-center, prospective, study enrolling Raptiva® (efalizumab) treated patients with moderate to severe chronic plaque psoriasis. The overall duration of the study is approximately 4 years. Patients will be followed from the time of study enrolment to study/treatment termination; thus active follow-up period will vary across subjects. Raptiva® (efalizumab)treated patients with moderate to severe chronic plaque psoriasis and meeting the inclusion/exclusion criteria specified will be eligible for participation in this study.
Objectives:
- To document and quantify the incidences of adverse events in this patient population
- To explore the association of psoriasis treatments with changes in patient outcomes, quality of life, and treatment compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consenting Raptiva® (efalizumab) treated patients with moderate to severe chronic plaque psoriasis and meeting the inclusion/exclusion criteria specified will be eligible for participation in this study. Subjects will be enrolled from the Raptiva®-treated clinical patient pool at the participating Canadian investigator site.
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years old.
- Have a clinical diagnosis of moderate to severe chronic plaque psoriasis and be a candidate for treatment with Raptiva®.
- Are being treated or are initiating treatment with Raptiva® at time of study enrolment in accordance with the Canadian Product Monograph indication and recommendations.
- Be able to provide written informed consent.
- Agreement to participate in the study, and to disclose any medical events to the Investigator.
Key exclusion criteria (2 listed)
- Any contra-indication to Raptiva® according to the Canadian Product Monograph.
- Any simultaneous participation in another clinical evaluation trial for psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All serious and unexpected AEs
Time frame: During the course of the study
1 secondary outcome
Investigator assessed: static Physician's Global Assessment (sPGA). Patient assessed: Dermatology Life Quality Index (DLQI)
Time frame: During the course of the study, there are no pre-defined scheduled visits
Results and safety
The study was stopped early (reason given: The study was terminated after the EMEA recommended to suspend the marketing authorisation of Raptiva in the EU). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horia Ijacu, MD study director
EMD Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated after the EMEA recommended to suspend the marketing authorisation of Raptiva in the EU). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All serious and unexpected AEs (time frame: During the course of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.